Evaluation For The Safety Of Frontlineodptm In A Multidose Randomized Cohort Study Compared With Pf24
Posted Date: Apr 18, 2024
- Investigator: Jose Cancelas
- Specialties:
- Type of Study: Device
The primary objective of this study is to assess the safety of autologous single infusions of FrontlineODP (on demand plasma) units at increasing doses of 1 unit (approximately 200 mL; Cohort 1), 2 units (approximately 400 mL; Cohort 2), and 4 units (approximately 800 mL; Cohort 3) in healthy subjects. The secondary objectives of this study are: To assess the safety of 4 FrontlineODP unit infusions (approximately 800 mL) compared with infusion of the same dose of autologous plasma refrigerated within 8 hours of collection and frozen within 24 hours of collection (PF24); Changes in coagulation factors after infusion of 4 units of FrontlineODP compared with infusion of the same dose of PF24
Criteria:
1. Males And Nonpregnant/Nonbreastfeeding Females 2. For Females, A Minimum Weight Of 140 Pounds And Maximum Weight Of 220 Pounds; For Males, A Minimum Weight Of 140 Pounds And A Maximum Weight Of 250 Pounds 3. Subject Is 18 To 65 Years Of Age, Inclusive. 4. Subject Self-Reports That He Or She Feels Well And Healthy. 5. Subject Scores =35 On The Duke Activity Status Index 6. Subject Is Able To Donate A Unit Of Plasma By Plasmapheresis Based On The Association For The Advancement Of Blood & Biotherapies (Aabb) Donor History Questionnaire With Modifications Indicated: Subjects With History Of Travel, Which Puts Them At Risk For Creutzfeldt-Jakob Disease Or Malaria, Are Eligible To Participate. 7. Subject Has Completed A Vaccination Course For Severe Acute Respiratory Syndrome Coronavirus 2 (Sars-Cov-2), With The Final Vaccine Injection Administered At Least 2 Weeks Before Enrollment. 8. Subject Has Read The Educational Materials On Donating Blood And Has Had His Or Her Questions Answered. 9. Subject Is Able And Willing To Provide Written Informed Consent. 10. Females Of Childbearing Potential Should Either Be Surgically Sterile (Hysterectomy Or Tubal Ligation) Or Should Use A Highly Effective Medically Accepted Contraceptive Regimen. Highly Effective Methods Of Birth Control Are Defined As Those Which Result In A Low Failure Rate (Ie, Less Than 1% Per Year) When Used Consistently And Correctly Such As Implants, Injectables, Combined Oral Contraceptives, Some Intrauterine Devices, Sexual Abstinence, Condoms With Spermicide, Or Vasectomized Partner. Note: Subjects Should Not Become Pregnant For At Least 3 Months After The Last Infusion Of Study Product. 11. All Females Must Have A Negative Urine Or Serum Pregnancy Test. 12. Subject Understands The English Language
Keywords:
Spray-Dried Plasma, Safety Phase I, Dose-Escalation
For More Information:
Jose A Cancelas
15133760250
jose.cancelas@uc.edu